Kornimate/medical-research-clean huggingface dataset:
a registry of treatment adherence for patients with schizophrenia

Conditions: Schizophrenia; Psychotic Disorders

Summary: the purpose of the study is to assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotic medications.

recent studies have suggested the superior effectiveness of second generation (atypical) antipsychotic medications over first generation (conventional) antipsychotics in preventing relapse during the treatment of schizophrenia. it is estimated that a majority of patients with schizophrenia have difficulty adhering to the daily regimen of oral medications, and the use of long-acting injectable antipsychotics has been shown to increase compliance. this study includes both retrospective and prospective observations of the treatments and outcomes associated with antipsychotic drug therapy as well as characteristics of the patient population. the study is not product specific and includes patients using therapy with long-acting injectable, tablet, or liquid formulations of conventional or atypical antipsychotic medications. all patients who enroll in the study start treatment with a new antipsychotic medication, which is to be used according to the product labeling in the local country. retrospective data, collected over a minimum of 12 months, include patient diagnosis, age, sex, history of treatment with antipsychotic medications, hospitalization, clinical global impression of severity of disease (cgi-severity), global assessment of functioning (gaf), and the reason for starting a new antipsychotic treatment. prospective data, collected every 3 months over 2 years, are evaluated to assess the effectiveness of treatment and include the patient's adherence to antipsychotic medication, cgi-severity, gaf, and clinical deterioration of the patient's condition. the study investigator enters the data into a registry either electronically or on paper record forms. safety assessments include the incidence, type and severity of adverse events throughout the prospective phase of the study. atypical or conventional antipsychotics, as tablet, liquid or injectable formulations as prescribed

Eligibility criteria:
inclusion criteria: * patients starting treatment with a new antipsychotic medication, in accordance with product labeling in the local country * permitted by their physician and by the patient to participate in a clinical trial exclusion criteria: * patients not meeting all of the inclusion criteria for entry into the study

Keywords: risperidone long-acting injection antipsychotic medication schizophrenia treatment retention observational study
a study evaluating the effect of botulinum toxin type a on semen quality in patients with benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: this is a 24 week study evaluating the effects of botulinum toxin type a on semen quality in patients with signs and symptoms of benign prostatic hyperplasia (bph).


Eligibility criteria:
inclusion criteria: * symptoms due to an enlarged prostate * able to provide semen samples at required visits. exclusion criteria: * previous use of any botulinum toxin for the treatment of any urological condition * history of vasectomy * history of undescended testicles or testicular trauma * subject who has not ejaculated for greater than 1 year * history of prostate infection or any sexually transmitted disease, such as gonorrhea, within the previous 12 months * history of bladder stones * history of cancer in the prostate, testicles, or bladder * previous use of chemotherapy for cancer treatment * history of urinary incontinence * previous prostate surgery
rapid assessment of cardiac markers for the evaluation of acute coronary syndrome (race-acs)

Conditions: Acute Coronary Syndrome

Summary: this clinical trial is being conducted to 1) evaluate the possible usefulness of a panel of cardiac markers in assessing emergency department patients with possible acute coronary syndrome, 2) evaluate the usefulness of bnp in assessing emergency department patients with possible acute coronary syndrome, 3) determine if bnp can be used to predict adverse events during hospitalization and in the emergency department, and 4) evaluate how a point-of-care testing platform affects resource utilization in the emergency department.

the correct diagnosis of acute coronary syndrome (acs) remains a frequent significant challenge for emergency physicians. over eight million chest pain patients present annually and despite promising advances in diagnosis, over four percent of acs patients are mistakenly discharged home. while the history and physical, cardiac risk factor assessment, ecg, and cardiac marker determination are all included in the assessment and risk stratification of patients presenting with possible acs, this assessment is clearly far from perfect. improved rapid and accurate means of assessment in this population in the ed are clearly needed.ed patients with chest discomfort will be screened and approached for study enrollment. consenting patients meeting the study inclusion and exclusion criteria will be enrolled. point-of-care serial cardiac marker measurements will be performed. based on a web-based computerized randomization system, half (50%) the patients willundergo routine central laboratory testing only. half (50%) of the patients will undergopoint-of-care markers performed in the ed in addition to routine central laboratory testing.in this second group, central laboratory test results will be blinded from the ed physicianuntil the disposition time. bnp will be blinded and not reported to physicians for the first 500 patients (phase i). after the first 500 patients have been enrolled, an interim analysis will be performed to determine the clinical utility of bnp in patient assessment. after physician education of these results, the trial will resume for the remaining 500 patients (phase ii). in phase ii, bnp levels will be provided to the physicians using the same time and randomization format.the patients and their medical records will be followed for a period of thirty days and sixmonths after enrollment.

Eligibility criteria:
inclusion criteria: age greater than or equal to 21 years at the time of enrollment chest discomfort or other symptoms consistent with possible acs as indicated by the treating physician obtaining an ecg and cardiac markers for the patient's evaluation new onset or worsening symptoms within six hours of presentation to the ed. exclusion criteria: history of chf per patient history or in the available medical record. history of end stage renal disease on dialysis. refused informed consent.4) refused medical record review and telephone follow up at 30 days and six months.
performance of an investigational blood glucose monitoring system in a clinical trial

Conditions: Diabetes

Summary: subjects with diabetes and study staff used an investigational blood glucose monitoring system.


Eligibility criteria:
inclusion criteria: * males and females, 18 years of age and above * diagnosed as having type 1 or type 2 diabetes * currently self-testing blood glucose at home for at least three months * able to speak, read, and understand english * willing to complete all study procedures exclusion criteria: * gestational diabetes * hemophilia or any other bleeding disorder * employee of competitive medical device company
copeptin after an oral stimulation with macimorelin in healthy volunteers

Conditions: Polyuria-polydipsia Syndrome

Summary: this study investigates stimulation of the posterior pituitary gland by oral macimorelin (a ghrelin receptor agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.

copeptin measurements upon intravenous arginine stimulation discriminate patients with diabetes insipidus versus patients with primary polydipsia with a high diagnostic accuracy. an oral test would be easier to perform, causes less risks and discomfort for the patients and would require less resources in clinical practice. this study investigates stimulation of the posterior pituitary gland by oral macimorelin (a ghrelin receptor agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.

Eligibility criteria:
inclusion criteria: * no medication except hormonal contraception exclusion criteria: * body mass index (bmi) \> 40kg/m2 or bmi \< 18.5 kg/m2 * participation in a trial with investigational drugs within 30 days * vigorous physical exercise within 24 hours before the study participation * alcohol intake within 24 hours before study participation * pregnancy and breastfeeding * evidence of disordered drinking habits and diuresis defined as polyuria \>50ml/kg body weight/24h and polydipsia \>3l /24h * a prolonged qt interval (qtc \>500 ms) or concomitant treatment with drugs that prolong the qt/qtc. * intention to become pregnant during the course of the study * known allergy towards macimorelin

Keywords: copeptin macimorelin ghrelin receptor agonist posterior pituitary gland polyuria-polydipsia syndrome hypothalamo-pituitary-adrenal axis
a study of abp 215 versus bevacizumab in chinese subjects with advanced non-squamous non-small cell lung cancer

Conditions: Metastatic Non-small Cell Lung Cancer (NSCLC); Non-squamous NSCLC

Summary: the purpose of this research study is to assess the efficacy and safety of abp 215 compared to bevacizumab in chinese patients with advanced non-small cell lung cancer (nsclc).

approximately 170 subjects will be randomized 1:1 in approximately 40 sites in china. this study consists of a screening period of up to 28 days, followed by a treatment period of 18 weeks, and an end of study visit 3 weeks after the last dose of investigational product or study-specified chemotherapy. after randomization, subjects will receive investigational product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4 and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-squamous nsclc. * subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 and no more than 6 cycles of chemotherapy. * eastern cooperative oncology group (ecog) performance status score 0 or 1. * other inclusion criteria may apply. exclusion criteria: * small cell lung cancer (sclc) or mixed sclc and nsclc. * central nervous system (cns) metastases. * malignancy other than nsclc. * palliative radiotherapy for bone lesions inside the thorax. * prior radiotherapy of bone marrow. * active hepatitis b. * active hepatitis c. * tested positive for human immunodeficiency virus (hiv). * life expectancy \< 6 months. * woman of childbearing potential who is pregnant or is breast feeding. * woman of childbearing potential who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment. * man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment. * other exclusion criteria may apply.

Keywords: biosimilar bevacizumab carboplatin paclitaxel
chat-based instant messaging support health education program

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to explore the effectiveness of a ckd-specific chatbot-based instant messaging support health education (cim-she) program and determine its user evaluation by ckd patients. a pre- and post-study design was employed and 60 patients were invited to join a three-month program for chronic kidney disease health education; 55 successfully completed the intervention. data were collected from april to november, 2020, using a structured questionnaire. paired t-tests and generalized equation estimation were used to examine the intervention effectiveness and users' evaluation.


Eligibility criteria:
inclusion criteria: 1. adults over 20 years old 2. diagnosed chronic kidney disease 3. the ability to operate technologies 4. intact cognition exclusion criteria: who was undergoing kidney dialysis, unconsciousness, dementia, or any other mental illness.

Keywords: chronic kidney disease chatbot push notification users' evaluation
improving dental health among toddlers in the dominican republic

Conditions: Dental Caries in Children; Dental Caries

Summary: caries prevalence in the dominican republic (dr) seems high, although recent information is lacking. in dr there is a growth and development program for all children from the age of 0 to 5.even though there is a mandatory educational health program for children and parents in this program, where periodically pediatricians examine them, this program does not include oral health education/prevention. thus, it is proposed a) to devise materials to be used by pediatricians to share relevant information about caries control to parents of toddlers, and b) to evaluate the impact of such material on caries prevention for groups of toddlers over a 1.5-year period. educational material will be developed for parents, and the pediatricians will deliver this material to 10-months-old children randomly selected at plaza de la salud hospital. the pi will train the pediatricians in caries prevention and how to deliver the information to the parents in a clear manner. a total of 306 will be allocated into two groups. the experimental group (128 children) will receive the devised educational materials at 10 months, follow-up information will be provided at growth and development visits when the child is 18-, and 24 months old. the second group will be considered as the control group and will not receive any educational materials (178 children). all the enrolled children will receive fluoride containing toothpaste and tooth brushes. after 18 months when the children will be about 3 years old they will be examined to assess dental caries status. a sample mortality rate of 40% is expected during the two-year follow-up. differences in caries status between the two groups will be examined using welch's independent t-tests for unequal variances.


Eligibility criteria:
inclusion criteria: * healthy children * parents agreed to participate in the program exclusion criteria: -
antibiotic prophylaxis in prosthetic breast reconstructions

Conditions: Surgical Site Infections

Summary: the added benefit of prolonged antibiotic prophylactic treatment in patients undergoing breast reconstruction who have drains placed for several days after surgery is controversial. in this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains. patients will sign an informed consent form prior to the surgery and will be randomized to one of the antibiotic regimens. patients will be closely followed up to one year after surgery. the number of surgical site infections according to the nnis criteria and loss of breast implants will be compared between the two groups.


Eligibility criteria:
inclusion criteria: all criteria should be present: 1. signing an informed consent form 2. reconstructive breast surgery 3. one drain or more remained after surgery - exclusion criteria: age \< 18 years active infection at the surgical site at the operation time or in close proximity to the surgical site immune deficiency state -

Keywords: surgical site infection breast reconstruction drains prophylaxis
pharmacokinetics/pharmacodynamics of oral salmon calcitonin in patients with osteoarthritis

Conditions: Osteoarthritis

Summary: the purpose of this study is to expose patients with oa to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin and 200 iu nasal calcitonin. also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) and 200 iu nasal calcitonin compared to placebo on serum ctx-i and ctx-ii. finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.


Eligibility criteria:
inclusion criteria: * medical history and symptoms of knee osteoarthritis exclusion criteria: * any other disease or medication affecting the bone or cartilage. * any clinical signs or laboratory evidence diseases, which in the investigator's opinion would preclude the participant from adhering to the protocol or completing the trial.

Keywords: osteoarthritis, oral salmon calcitonin, tolerability, biomarkers
special investigation of j zoloft for panic disorder patients

Conditions: Panic Disorder

Summary: the objective of this surveillance is to collect information for panic disorder patients about 1) adverse drug reactions not expected from the lpd (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

all patients with panic disorder to whom an investigator prescribes the first sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: patients with panic disorder need to be taking sertraline hydrochloride in order to be enrolled in the surveillance. exclusion criteria: patients not taking sertraline hydrochloride.
clinical evaluation of ezvent in hospitalized mechanically ventilated patients

Conditions: Respiratory Failure; Respiratory Disease

Summary: investigation device: ezvent ventilator system is designed for respiratory support in hospitalized mechanical ventilated patients. the ventilator is designed to be used for adults patients. it is designed to be a stationary product suitable for service in hospitals, critical care situations to provide continuous positive pressure respiratory support to the patient. the ventilator met eda, iso 80601-2-12 requirements on essential performance of critical care ventilator and other applicable international standards. study title: open-labeled, non-randomized, self-controlled study to evaluate the safety and performance of ezvent in hospitalized mechanically ventilated patients. investigational device ezvent ventilator system. purpose: evaluation of the safety and performance of ezvent in hospitalized mechanically ventilated patients. objectives: evaluation of the safety and performance of ezvent through monitoring the vital signs and arterial blood gases (abg) in comparison to a commercial ventilator.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 years or above. * mechanically ventilated patients (on either vc, pc or cpap modes). * able (in the investigators opinion) and willing to comply with all study requirements. * considered clinically stable, with fio2 less than 60% and peep no greater than 10 cm h2o exclusion criteria: * pregnant women * patients who experienced myocardial infarction within the last 6 weeks. * shocked patients, hemodynamic instability requiring vasopressors, cardiac arrhythmias, terminal malignancy. * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Keywords: ezvent ventilator mechanical ventilator respiratory failure medical device ventilator performance egyptian ventilator ventilator clinical evaluation ventilator clinical investigation ezvent clinical evaluation
study to evaluate the safety, tolerability, and efficacy of otx-tki in subjects with moderately severe to severe non-proliferative diabetic retinopathy

Conditions: Non-proliferative Diabetic Retinopathy

Summary: evaluate the safety, tolerability, and efficacy of otx-tki in subjects with moderately severe to severe non-proliferative diabetic retinopathy

multicenter, double-masked, randomized, parallel group study to evaluate the safety, tolerability, and efficacy of otx-tki (axitinib implant) for intravitreal injection in subjects with moderately severe to severe non-proliferative diabetic retinopathy

Eligibility criteria:
inclusion criteria: * are at least 18 years of age or older * moderately severe to severe npdr in the study eye defined as: drss levels of 47 or 53 as determined by the reading center * diabetes type 1 or 2 * bcva etdrs letter score in the study eye of ≥69 letters (approximate snellen equivalent of 20/40 or better) exclusion criteria: * dme within 6 months involving the center of the macula in the study eye * presence of dme threatening the center (within 200 microns) of the macula in the study eye * oct csft of ≥320 μm in the study eye

Keywords: nonproliferative diabetic retinopathy diabetic retinopathy otx-tki
association between dietary factors and chronic subdural hematoma (dish)

Conditions: Chronic Subdural Hematoma

Summary: a prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.

chronic subdural hematoma (csdh) is one of the most common neurosurgical conditions, which is considered to be an inflammatory disease. dietary factors can have an impact on the inflammatory mechanism in human body, which can increase a variety of inflammatory biomarkers in the blood. the risk of malnutrition in the elderly is generally high, and nutritional status can affect the risk of csdh in the elderly. little is known about the association of dietary factors with csdh. the investigators speculate that dietary factors participate in and promote the occurrence and development of csdh. this study will clarify whether there is a correlation between dietary factors and csdh, which will reveal the pathogenesis and prevention of csdh.

Eligibility criteria:
case group (csdh group) inclusion criteria: * patients (18 years to 90 years) presenting with clinical symptoms and neurological deficits of csdh. * csdh verified on cranial computed tomography or magnetic resonance imaging. * written informed consent from patients or their next of kin according to the patient's cognitive status. control group (healthy group) inclusion criteria: * non-csdh patients (18 years to 90 years) with matched age and gender. * written informed consent from patients or their next of kin according to the patient's cognitive status. exclusion criteria for both case and control group: * previous intracranial surgery for any neurological disorders but chronic subdural hematoma before. * csdh turned from acute subdural hematoma. * existing malignant tumors, poor medication condition or severe comorbidity. * difficulty in feeding requiring long-term enteral or parenteral nutrition support. * dietary and nutritional survey is estimated to be completed difficultly. * reproductive-age women without verified negative pregnancy testing. * participating in other research.

Keywords: chronic subdural hematoma dietary inflammatory index food frequency questionnaire modified frailty index